Medical device CE marking

RoHS 2 applicable for Medical Devices per 22 July 2014

RoHS 2 is an update to the European Directive 2002/95/EC that limits the use of certain specified hazardous substances to be placed on the EU market from 1st January 2006. The new RoHS Directive 2011/65/EU (RoHS 2) became effective on 3 January 2013. RoHS 2 deals with the same hazardous substances and the same maximum concentration limits as Directive 2002/95/EC (RoHS 1).

The Directive shall apply to medical devices which are placed on the market from 22 July 2014. There is an extended transition period for in vitro diagnostic (IVD) equipment (until 22 July 2016).

Those affected by this Directive are producers of Electrical and Electronic Equipment (known as EEE). They must ensure that their products and the components of such products comply with the requirements of the Directive.